Actively Recruiting
Prospective Randomized Controlled Trial Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia for Total Knee Arthroplasty
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-01-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of different doses of glucocorticoids added to local infiltration analgesia (LIA) during total knee arthroplasty (TKA). This prospective single-center randomized controlled trial aims to find the best dose to manage pain after TKA, improve recovery, and enhance patients' quality of life following surgery. Participants will be randomly assigned to one of four groups: high-dose LIA with 3 vials of Diprospan, medium-dose with 2 vials, low-dose with 1 vial, or a control group receiving LIA without Diprospan. Diprospan contains betamethasone and betamethasone dipropionate, and the study compares these varying doses to assess their impact on pain control. During the study, pain levels will be measured using the Visual Analog Scale (VAS) at baseline and multiple time points up to 6 weeks after surgery. Additional assessments include the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), range of motion, and various blood tests to monitor inflammation and organ function. Researchers will also track postoperative analgesic use and the incidence of complications up to 6 months. The total study duration includes follow-up visits at 3 and 6 weeks postoperatively.
CONDITIONS
Brief Title
Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Undergoing primary unilateral total knee arthroplasty for unilateral knee osteoarthritis at the study hospital
- Preoperative physical status classified as American Society of Anesthesiologists (ASA) class 1 to 3
- Ability to provide and sign written informed consent
You will not qualify if you...
- Previous surgery or infection in the knee to be operated on
- Non-osteoarthritis knee conditions such as rheumatoid arthritis, traumatic arthritis, septic arthritis, or hemophilic arthritis
- Severe osteoarthritis with flexion contracture over 30 degrees or varus/valgus deformity over 30 degrees
- Allergy to study drugs including corticosteroids
- Neuromuscular dysfunction in the same limb as the surgery
- Dependence on anesthetic drugs with weekly opioid use over 100 mg morphine equivalents or local anesthetics for more than 3 months before surgery
- Poor overall health including high HbA1c over 12%, high blood pressure over 170/110 mmHg, recent serious heart or brain events within 6 months, dialysis or kidney transplant, pregnancy, or breastfeeding
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until hospital discharge
Participants undergo total knee arthroplasty with local infiltration analgesia (LIA) using different doses of corticosteroids (Diprospan) or no corticosteroids as part of the study intervention.
1 surgery visit and several postoperative visits within 6 weeks
Duration - Up to 6 months postoperatively
Participants are monitored for pain, knee function, range of motion, blood markers, and potential complications after surgery.
Multiple visits at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, 6 weeks, and monitoring for complications up to 6 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
Actively Recruiting
Research Team
C
Chaofan Zhang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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